There is confusion in the medical profession as to the causes and appropriate treatments for premature ejaculation. In fact, there are a variety of definitions used to describe premature ejaculation. For example, the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) defines premature ejaculation as ejaculation that occurs without control or as occurring shortly after penetration and before a person wishes it, causing marked distress or interpersonal difficulty (American Psychiatric Association, “Diagnostic and statistical manual of mental disorders,” 4th edition, Washington DC: APA 2000). Other definitions of premature ejaculation incorporate a time factor, namely, as ejaculation that occurs always or nearly always before or within about one minute of vaginal penetration, an inability to delay ejaculation on all or nearly all vaginal penetration, and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy (International society for sexual medicine, ISSM, http://www.issm.info/education-for-all/featured-education/). Still other definitions of premature ejaculation involve expectations of the partner, particularly regarding the ability to climax. Masters and Johnson (1970) proposed one of the earliest definitions that focused on the inability to delay ejaculation long enough for women to achieve orgasm fifty percent of the time (Masters W. H. & Johnson V. E., “Human Sexual Inadequacy,” Boston: Little, Brown, 1970).
For purposes of the present invention, the inventor have adopted the following definition. Premature ejaculation in accordance with the invention has any one or more of the following characteristics:
i. Ejaculating before or within five minutes after penetration;
ii. Not having control of your ejaculation; and/or
iii. Ejaculating before you have satisfied your partner.
Furthermore, in the context of the invention it is important to differentiate between primary and secondary premature ejaculation. Primary is life long and stems from the very first sexual encounter, while secondary is an acquired form (Godpodinoff M. L., “Premature ejaculation: clinical subgroups and etiology,” J Sex Marital Therapy, 1989; 15:130). In the inventors' clinical experience, secondary (acquired) premature ejaculation tends to occur in older patients and is usually the result of an underlying problem of erectile dysfunction. As a result of the inability to sustain an erection, the patient ejaculates more rapidly, learning to climax before the loss of his erection. Hence, the treatment of secondary premature ejaculation falls under the umbrella of treatment for erectile dysfunction. When both premature ejaculation and erectile dysfunction exist concurrently, erectile dysfunction should be treated first (American Urological Association, “Guideline on the pharmacologic management of premature ejaculation,” Drogo et al 1999).
In the case of secondary premature ejaculation, that is, premature ejaculation occurring as a result of an erectile problem, treatment involves treating the cause of erectile dysfunction rather than premature ejaculation per se. The treatment of secondary premature ejaculation is not covered herein but distinguishing between the two is important and will be addressed. Methods and compositions for treating erectile dysfunction may be found, for example, in U.S. Pat. No. 7,405,222, to Ramsey Sallis et al. The treatment protocol in accordance with the invention addresses only patients with primary premature ejaculation.
Prevalence of Premature Ejaculation
Premature ejaculation is reported to be the most common sexual dysfunction in men (Montague D. K. et al., “AUA guideline on the pharmacologic management of premature ejaculation,” J Urol. 2004; 172:290-294). A study involving 1,234 males showed the following percentages reporting a prevalence of premature ejaculation (Laumann E. O. et al., “Sexual dysfunction in the United States: prevalence and predictors,” JAMA 1999; 281:537):
AgeTotal (1234)Percent (%)18-2912130%30-3912232%40-49 8328%50-59 5531%Some studies show a considerably higher prevalence and results are generally quite variable. This is not surprising given that premature ejaculation is largely self-reported and even now there is little consensus regarding a universal definition. From the inventors' review of the literature, it appears that the more recent the study, the higher the prevalence, which could reflect changing expectations by partners regarding sexual performance.Causes of Premature Ejaculation
Erectile dysfunction was considered to have principally a psychological etiology up until the early 1990s. Numerous papers quoted incidents in the region of 80:20; 80% psychological and 20% physical. With the advent of more sophisticated diagnostic tools such as the eco-doppler machine for measuring blood flow, the tide has turned, with studies showing an organic detiology in 80-90% of patients (Feldman H. A., McKinlay J. B. et al., “Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study,” J Urol. 1994; 151:54).
The same shift appears to be happening regarding the aetiology of premature ejaculation, from the psychological to the organic. Although, to date, no single etiological theory has universal acceptance, there is a general shift toward the acceptance of the condition as one in which psychologically mediated processes exacerbate an underlying organic component (“Prevalence of premature ejaculation: a global and regional perspective,” Montorsi F., J Sex Med; 2005; Supplement 2, page 100).
The traditional psychological approach to premature ejaculation uses sexual conditioning as a factor as introduced by Masters and Johnson in their book Human Sexual Inadequacy, Boston: Little, Brown, 1970. For example, patients with premature ejaculation tend to exhibit a nervousness or tension during love making relating to an anxious personality type and stemming from the first sexual encounter.
The most popular organic theory regarding the aetiology of primary premature ejaculation relates to the penile hypersensitivity resulting in a lower ejaculatory threshold (Xin Z. C., Chung W. S. et al., “Penile sensitivity in patients with primary premature ejaculation,” J Urol. 1996; 156:979-81). In other words, little physical stimulation causes rapid ejaculation. This could explain why primary premature ejaculation is more common in uncircumcised men and why anesthetic creams or gels are part of many treatment protocols (Namavar M. R. & Robati B., “Removal of foreskin remnants in circumcised adults for treatment of premature ejaculation,” Urol Annals 2011, May-August; 3(2):87-92).
In the inventors' clinical experience, men with primary premature ejaculation tend to exhibit both of the following characteristics:
i. nervousness and tension during lovemaking, dating back to the very first sexual encounter; and
ii. a hypersensitivity of the glans penis, that is the head of the penis, resulting in a lower ejaculatory threshold.
As noted above, secondary premature ejaculation is premature ejaculation occurring as a result of an erectile problem. Obviously, in such cases treatment involves treating the cause of erectile dysfunction rather than premature ejaculation per se. The treatment of secondary premature ejaculation is not covered herein but distinguishing between the two is important and will be addressed.Diagnosis
Traditionally, the diagnosis of premature ejaculation has been based on sexual history alone, addressing only the first of the characteristics noted above. Of course, an extensive sexual history should be obtained from all presenting patients and, if agreed upon, their partners may be present. However, such a diagnosis is based on self-reporting. Particularly in this sensitive field of medicine, such self-reporting can often lead to under-reporting. Many men are reluctant to admit to the severity of the problem and its duration, and the effect on their lives, due to embarrassment.
A better diagnosis and treatment protocol is desired to assess premature primary premature ejaculation and distinguish it from secondary premature ejaculation. The invention addresses this significant need in the art by incorporating the traditional history taking with diagnostic testing to provide more tangible parameters.